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Latent Tuberculosis clinical trials

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NCT ID: NCT02073669 Completed - Latent Tuberculosis Clinical Trials

Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults

Start date: March 2014
Phase: N/A
Study type: Interventional

The aim of study is to evaluate the prevalence of latent TB in second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the control native Israelis without a family member who was born in a country with high incidence of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators expect that the second generation immigrants group will have more positive IGRA test than the control native group.

NCT ID: NCT02073240 Completed - Tuberculosis Clinical Trials

Evaluation of an Enhanced Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand

EnTIC
Start date: February 17, 2014
Phase:
Study type: Observational

Study Design: Stratified, matched, cluster-randomized, controlled trial Unit of Randomization: Healthcare facility Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare workers (HCWs) will be at measured at baseline, and LTBI incidence will be measured among susceptible HCWs at 12 and 24 months. Secondary outcomes will be measures at 0 (pre-intervention) 6, 12, 18, and 24 months. In year three, results will be analyzed and disseminated. Study Components: Assessment of institutional safety culture; observations/audits of Tuberculosis (TB) patient flow (wait times) and HCW TB infection control (IC) practices; documentation of time intervals for processing sputum smears and initiation of TB treatment; facility assessments; random allocation and implementation of enhanced Tuberculosis infection control (TB IC) package; testing of HCWs to determine LTBI at 0, 12, 24 months; cost evaluation of intervention. Sample Size: For the cluster randomized design, we estimate that 11 clusters per group will allow for 77 percent (%) power to identify a 30% reduction in LTBI incidence in the intervention vs. control clusters. This assumes LTBI incidence 5% per year in the control group, design effect for clustering of 2.0, and cluster size of 300 (average 600 HCW per cluster with 50% LTBI prevalence at baseline).

NCT ID: NCT01967134 Completed - Latent Tuberculosis Clinical Trials

Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis

Start date: November 2011
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, dose-escalation study with three study groups. This study will be conducted in 25 HIV negative subjects, 17 of whom will have Latent Tuberculosis Infection (LTBI) and 8 of whom will not have LTBI at study enrollment. The investigational product is AERAS-456 at a dose of 15 ug of H56 antigen with IC31 500 nmol KLK (15/500), and a dose of 50 ug of H56 antigen with IC31 500 nmol KLK (50/500). The vaccine is administered by intramuscular injection.

NCT ID: NCT01865487 Completed - Latent Tuberculosis Clinical Trials

A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)

Start date: August 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease. The investigational product is AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is administered by IM injection.

NCT ID: NCT01850043 Completed - Tuberculosis Clinical Trials

The Epidemiology of TST Change in Korea

Start date: May 2005
Phase: N/A
Study type: Observational

TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC recommendation. Participants with chest radiograph showing active TB lesion are excluded from this study.

NCT ID: NCT01622140 Completed - Tuberculosis Clinical Trials

Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis

Start date: October 2012
Phase:
Study type: Observational

This is a prospective cohort study of persons tested for latent tuberculosis infection at either high risk for exposure to Mycobacterium tuberculosis or high risk for progression to tuberculosis disease. The study will assess the relative performance and cost of three diagnostic tests for latent tuberculosis infection (tuberculin skin test, QuantiFERON-TB Gold In-Tube, and T-SPOT.TB) and will examine the rates of positive results among the cohort. This study will also determine the risk and rate of progression to active TB disease, overall and by the results of the three tests.

NCT ID: NCT01608685 Completed - Clinical trials for Latent Tuberculosis Infection

Interferon Gamma Release Assays (IGRA) Testing Versus Tuberculin Skin Test in Renal Transplant Recipients

Start date: January 2010
Phase: N/A
Study type: Observational

Interferon gamma release assays (IGRA) have been shown to be more specific and sensitive for the detection of tuberculosis (latent or active infection) than the tuberculin skin test (TST) in immunocompetent individuals. However, very little data are available concerning the relative performance of IGRA and TST in immunosuppressed individuals from other causes than HIV. The investigators hypothesize that IGRAs would be more sensitive and specific than the TST in a group of renal transplant recipients under chronic immunosuppressive treatment for detecting latent tuberculosis infection.

NCT ID: NCT01601275 Completed - Tuberculosis Clinical Trials

Database of All Patients With Microbiologically Proven Mycobacteria Tuberculosis Infection

Start date: May 2012
Phase:
Study type: Observational

Prospective data collection of all patients with microbiologically proven mycobacteria tuberculosis infection treated at Singapore General Hospital.

NCT ID: NCT01582711 Completed - Clinical trials for Latent Tuberculosis Infection

Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT

iAdhere
Start date: September 2012
Phase: Phase 3
Study type: Interventional

The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The primary objective is to evaluate adherence to a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) given by directly observed therapy (DOT) compared to self-administered therapy (SAT). The secondary objectives: - To compare the treatment completion rates between participants randomized to SAT without reminders versus SAT with weekly SMS reminders - To evaluate the timing of doses and patterns of adherence to once weekly RPT/INH among participants who complete treatment and those who discontinue therapy prior to completion. - To determine the availability and acceptability of using SMS reminders among all patients consenting to participate in the study. - To determine the toxicity and tolerability by comparing the rates of any drug-related grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined and individually) - To compare the frequency, timing, and causes for failure to complete treatment between the DOT arm and the SAT arms - To collect patient-specific cost data related to the 3 treatment arms - To describe the pattern of antituberculosis drug resistance among Mycobacterium tuberculosis strains cultured from participants who develop active TB.

NCT ID: NCT01547884 Completed - Tuberculosis Clinical Trials

Effect of Filarial Infection on Immune Responses in Latent Tuberculosis

Start date: January 1, 2013
Phase:
Study type: Observational

Background: - Lymphatic filariasis is an infection that is caused by small, thread-like worms. It is spread by mosquitoes, and causes fever, chills, and headaches. If untreated, it can also cause elephantiasis, a condition that leads to swelling of the arms, legs, breasts, and scrotum. Treatment can eliminate the worms from the blood and reduce the risk of developing elephantiasis. Researchers want to study people with latent tuberculosis (TB) who may or may not be infected with filariasis. This study will look at the way that people with latent TB fight infection with these worms. Objectives: - To study how the immune systems of people with latent TB react to filarial infection. Eligibility: - Individuals between 18 and 65 years of age who have latent TB and may or may not have filarial infection. Design: - Participants will be screened with a physical exam and medical history. They will provide a blood and stool sample to test for infection. - Participants who do not have lymphatic filariasis but have another kind of intestinal worm will be treated for the parasite. This will be their last study visit. - Participants who have latent TB and lymphatic filariasis will be treated with the standard treatment for the disease. They will come back for a second visit 6 months later, and will provide another blood sample.